US FDA/CFSAN: Color Additive Status List Page 1 of 13 FDA Home Page | CFSAN Home | Search/Subject Index | Q & A | Help CFSAN/Office of Food Additive Safety September 2006 COLOR ADDITIVE STATUS LIST Formerly called Appendix A of the Investigations Operations Manual (IOM); New items are highlighted in yellow. If you are using an older web browser and you do not see the highlighting, you may download this document in PDF (77 KB) for printing. Food Additive Status List List 1 | List 2 | List 3 | List 4 | List 5 | List 6 | List 7 | Preface This status list provides current information concerning color additives, and will enable you to determine the status and limitations of most color additives likely to be encountered in a food, drug, device, or cosmetic establishment. To maintain concise form, this list is limited in many respects involving certification, regulations, labeling, etc. For specific details concerning these matters, please refer to the source documents, Code of Federal Regulations (CFR, Title 21, Parts 70 to 82) and to the Federal Food, Drug, and Cosmetic Act, as amended, Sections 601(e), 602(e), 706, [21 U.S.C. 361(e), 362(e), 376] and as it pertains to Sections 201(s)(3) and (t), 402(c), 403(m), 501(a), and 502(m) [21 U.S.C 321(s)(3), and (t), 342(c), 343(m), 351(a), and 352(m)]. Any color additives not included in this listing and found in the possession of manufacturers or processors where they may be used in foods, drugs, devices, or cosmetics should be referred to your district for consideration. Your Servicing Laboratory for color analysis is also a good reference source. LAKES: Color additive lakes are provisionally listed under 21 CFR 81.1. Part 82 of 21 CFR explains how lakes may be manufactured and named and lists the color additives that may be used to manufacture lakes. All lakes are subject to certification. Examples of nomenclature of lakes: z The name of a lake is formed from the name of the color additive combined with the name of the basic radical and the word "Lake". For example, the name of the lake prepared by extending the aluminum salt of FD&C Blue No. 1 upon alumina would be FD&C Blue No. 1 - Aluminum Lake. z If a lake is prepared by extending an FD&C color additive on a substratum other than alumina, the symbol "FD&C" will be replaced by "D&C". For example, the name of the http://www.cfsan.fda.gov/~dms/opa-appc.html 11/9/2006 US FDA/CFSAN: Color Additive Status List Page 2 of 13 lake prepared by extending the aluminum salt of FD&C Blue No. 1 upon a substratum other than alumina would be D&C Blue No. 1- Aluminum Lake. NOTE: You are cautioned that this Exhibit is condensed and should be used for screening and guidance only. When you encounter situations involving possible violations of color additive regulations check the latest basic document as indicated in the second paragraph of this preface. Be certain of the complete status and report the facts. It is the district responsibility to instigate appropriate action, not yours. Do not advise firms to destroy stocks of possible suspect merchandise or institute recalls without district clearance. LIST 1 Color additives subject to certification and permanently listed (unless otherwise indicated) for use in FOOD. Most are also listed for use in DRUGS AND COSMETICS as noted. (None of these colors may be used in products that are for use in the area of the eye, unless otherwise indicated). FD&C Blue #1 - Food, drugs and cosmetics, including drugs and cosmetics for eye area - GMP - 74.101, 74.1101, 74.2101, 82.101 FD&C Blue #1 Aluminum Lake - Drugs and cosmetics for eye area - GMP - 74.1101, 74.2101, 82.101 FD&C Blue #2 - Food and ingested drugs - GMP - 74.102, 74.1102; sutures - see medical devices - 74.3102. FD&C Blue #2 Aluminum Lake on alumina - Bone cement - see medical devices - 74.3102, 82.102 FD&C Green #3 - Food, drugs and cosmetics - GMP - 74.203, 74.1203, 74.2203, 82.203 FD&C Red #3 - Food and ingested drugs - GMP - 74.303, 74.1303. May no longer be used in cosmetics, external drugs, and lakes FD&C Red #40 and its Aluminum Lake - Food, drugs and cosmetics, including drugs and cosmetics for eye area - GMP. Other lakes for food, drugs and cosmetics are also permanently listed - 74.340, 74.1340, 74.2340 FD&C Yellow #5 - Food, drugs and cosmetics, including drugs and cosmetics for eye area - GMP - 74.705, 74.1705, 74.2705, 82.705 FD&C Yellow #5 Aluminum Lake - Drugs and cosmetics for eye area - GMP - 74.1705, 74.2705, 82.705 FD&C Yellow #6 - Food, drugs and cosmetics - GMP - 74.706, 74.1706, 74.2706, 82.706 FD&C Lakes (See Preface of this exhibit) - Provisionally listed. May be prepared from any of the above certified FD&C colors, except FD&C Red #3 - GMP - 81.1, 82.51 Citrus Red #2 - Skins of mature oranges - ≤ 2 ppm by wt. of whole fruit - 74.302 Orange B - Surfaces and casings of frankfurters or sausages - ≤ 150 ppm by wt. of finished product - 74.250 http://www.cfsan.fda.gov/~dms/opa-appc.html 11/9/2006 US FDA/CFSAN: Color Additive Status List Page 3 of 13 Use of the following color additives is no longer authorized or has been restricted: z FD&C Green #1 - Removed from list - 81.30(d) z FD&C Green #2 - Removed from list - 81.30(d) z FD&C Red #1 - Removed from list - 81.10(c), 81.30(b)(1) z FD&C Red #2 - Removed from list - 81.10(f), Feb. 13, 1976 - 81.30(j) z FD&C Red #3 - All lakes, all cosmetics, and external drugs removed from list - 81.10(u), Feb. 1, 1990 - 81.30(u). Use of FD&C Red #3, but not its lakes, in food and ingested drugs is allowed. z FD&C Red #4 - Food, ingested drugs, and ingested cosmetics removed from list. Use in externally applied drugs and cosmetics is allowed - 81.10(d), Sep. 23, 1976 - 81.30(c). z FD&C Violet #1 - Removed from list - 81.10(e), Apr. 10, 1973 - 81.30(h) LIST 2 Color additives subject to certification and permanently listed (unless otherwise indicated) for DRUG AND COSMETIC use. (None of these colors may be used in products that are for use in the area of the eye unless otherwise indicated) D&C Black #2 - Only for the following cosmetics: eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foundation, and nail enamel - GMP - 74.2052 D&C Green #5 - For drugs and cosmetics including drugs and cosmetics for eye area - GMP - 74.1205, 74.2205, 82.1205 D&C Orange #5 - Drugs: mouthwashes and dentifrices that are ingested drugs (GMP), and external drugs (at most 5 mg per day). Cosmetics: lipsticks (at most 5% by wt. of finished product), mouthwashes and dentifrices that are ingested cosmetics, and external cosmetics (GMP) 74.1255, 74.2255, 82.1255 D&C Red #6 - For drugs (combined total of D&C Red No.6 & D&C Red No. 7 < 5 mg per day); For cosmetics (GMP) -74.1306, 74.2306, 82.1306 D&C Red #7 - For drugs (combined total of D&C Red No.6 & D&C Red No. 7 < 5 mg per day); For cosmetics (GMP) -74.1307, 74.2307, 82.1307 D&C Red #21 - For drugs generally and cosmetics - GMP -74.1321, 74.2321, 82.1321 D&C Red #22 - For drugs generally and cosmetics - GMP -74.1322, 74.2322, 82.1322 D&C Red #27 - For drugs generally and cosmetics - GMP -74.1327, 74.2327, 82.1327 D&C Red #28 - For drugs generally and cosmetics - GMP -74.1328, 74.2328, 82.1328 D&C Red #30 - For drugs generally and cosmetics - GMP -74.1330, 74.2330, 82.1330 D&C Red #33 - Drugs: ingested drugs other than mouthwashes and dentifrices (at most 0.75 mg per day); and mouthwashes, dentifrices, and external drugs (GMP). Cosmetics: lipsticks (at most 3% by wt. of finished product); and mouthwashes, dentifrices and external cosmetics (GMP) 74.1333, 74.2333, 82.1333 http://www.cfsan.fda.gov/~dms/opa-appc.html 11/9/2006 US FDA/CFSAN: Color Additive Status List Page 4 of 13 D&C Red #36 - Drugs: ingested drugs, other than mouthwashes and dentifrices, if taken continuously for < 1 year (at most 1.7 mg per day); ingested drugs if taken continuously for > 1 year (at most 1.0 mg per day); and external drugs (GMP). Cosmetics: lipsticks (at most 3% by wt. of finished product), and external cosmetics (GMP) 74.1336, 74.2336, 82.1336 D&C Yellow #10 - For drugs generally and cosmetics -GMP -74.1710, 74.2710, 82.1710 D&C Lakes (See Preface of this Exhibit) - Provisionally listed. May be prepared from any of the FD&C or D&C color additives listed in part 82 Use of the following color additives is no longer authorized or has been restricted: z D&C Black #1 - Sep. 4, 1966 - 81.30(d) z D&C Blue #6 - Use in drugs and cosmetics is no longer authorized. 81.10(n); use in sutures is allowed (Dec. 13, 1977) - 81.30(o) z D&C Blue #7 - Sep. 4, 1966 - 81.30(d) z D&C Green #6 - Use in ingested drugs and ingested cosmetics is no longer authorized Mar.